Biosimilars Naming and Labeling

Biosimilars Naming and Labeling A Study of U.S. Pharmacists

Kevin Olson, CEO Industry Standard Research

[email protected] October, 2015

Methodology 10 Biosimilars Knowledge 14 Product Naming Attitudes and Beliefs 23 Label Contents Attitudes and Beliefs 35 Study Questionnaire

Table of contents

Pharmacists - Biosimilars Naming and Labeling 2 October 2015

METHODOLOGY ASBM

Study methodology •  401 pharmacists •  15-minute web-based survey •  All participants based in the U.S. •  Participants recruited from large, global panel of healthcare professionals •  Participants screened as follows:

–  Must be employed in either Hospital / Health System pharmacy or Retail pharmacy setting

–  Must dispense biologic medicines –  Must have been in practice as a pharmacist for 1 year or more

•  Participants received a standard cash stipend for their time •  Study was sponsored by ASBM and administered by Industry Standard

Research, LLC

Biosimilar Naming and Labeling 4 October 2015

Sample characteristics Practice Setting Years in Practice

0%

19%

21%

27%

22%

12%

0% 5% 10% 15% 20% 25% 30%

Less than 1 year

1-5 years

6-10 years

11-20 years

21-30 years

More than 30 years

% of Respondents

Hospital / Health

System, 60%

Retail, 40%


Familiarity with Orange Book

0%

4%

32%

64%

0% 10% 20% 30% 40% 50% 60% 70%

I've never heard of it

Vaguely familiar

Somewhat familiar

Very familiar

% of Respondents

•  Question –  “How familiar are you with the “Orange book”, that is,

the resource for Approved Drug Products with Therapeutic Equivalence Evaluations?”


Frequency of Orange Book use

6%

41%

24%

23%

6%

0% 5% 10% 15% 20% 25% 30% 35% 40% 45%

Never

Rarely

Monthly

Weekly

Daily

% of Respondents

•  Question –  “How often in your work do you use or refer to the

“Orange Book”?”


Familiarity with Purple Book

28%

34%

29%

9%

0% 5% 10% 15% 20% 25% 30% 35% 40%

I've never heard of it

Vaguely familiar

Somewhat familiar

Very familiar •  Question

–  “How familiar are you with the “Purple Book”, that is, the resource for Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations?”


Frequency of Purple Book use

49%

30%

12%

7%

2%

0% 10% 20% 30% 40% 50% 60%

Never

Rarely

Monthly

Weekly

Daily •  Question –  “How often in your work do you use or refer to the

“Purple Book”?”


BIOSIMILARS KNOWLEDGE

U.S. Pharmacists

Familiarity with biosimilars

0%

8%

57%

35%

0% 10% 20% 30% 40% 50% 60%

Have never heard of them

I've heard of them but could not define them

Familiar, have a basic understanding of them

Very familiar, I have a complete understanding of them

% of Respondents

•  Question –  “Biosimilar medicines are intended to be copies of

already approved biologic medicines. They are referred to as “biosimilar” rather than “generic” because they will be similar, but not identical to the product they copy. How familiar are you with biosimilar medicines?”

•  Segment Difference –  Hospital pharmacists are more likely to be “Very

familiar…” with biosimilars than retail pharmacists. 44% vs. 23%


Awareness of biosimilars approval process

Yes, 86%

No, 14% •  Question

–  “Originator medicines are approved by the US Food and Drug Administration based on an evaluation of clinical data that demonstrates a medicine is safe and effective for the specified indication and data must be provided for every indication. The approval pathway for biosimilars is different than for originator medicines. Are you aware a biosimilar medicine may be approved for several or all indications of the reference product on the basis of clinical trials in only one of those indications?”

•  Segment Difference –  Hospital pharmacists are more likely to respond “Yes”

than retail pharmacists. 91% vs. 78%


Acceptability of biosimilars approval process

2%

20%

51%

27%

0% 10% 20% 30% 40% 50% 60%

This is totally unacceptable

This is somewhat unacceptable

This is somewhat acceptable

This is totally acceptable

% of Respondents

•  Question –  “How do you feel about the fact that a biosimilar

medicine may be approved for several or all indications of the reference product on the basis of clinical trials in only one of those indications?”


NAMING U.S. pharmacists, biosimilars and

Same name = identical?

Yes, 63%

No, 30%

No opinion, 6% •  Question

–  “If two biologic medicines have the same non-proprietary scientific name, does this suggest to you or imply that the medicines are identical?”

•  Segment Difference –  Hospital pharmacists are more likely to answer “Yes”

than retail pharmacists. 68% vs. 57%


Same name = same result?

•  Question –  “If two biologic medicines have the same non-

proprietary scientific name, does this suggest to you or imply that a patient could receive either biologic product and expect the same result?”

Yes, 64%

No, 32%

No opinion, 4%


Same name = safe switching during treatment?


proprietary scientific name, does this suggest to you or imply that a patient could be safely switched from a reference biological medicine to its biosimilar during a course of treatment and expect the same result as with either of the products?”

Yes, 58%

No, 37%

No opinion, 5%


Same Name = Approved for the same indications?


proprietary scientific name, does this suggest to you the medicines are approved for the same indications?”

Yes, 55%

No, 41%

No opinion, 4%


Should FDA require distinct names?

•  Question –  “The FDA has proposed a new policy that would

require every biologic – whether originator or biosimilar – to have a distinct non-proprietary scientific name. In your opinion, should the FDA require a distinct non-proprietary scientific name for every biologic product – whether originator or biosimilar – approved by them?” Yes, 68%

No, 23%

No opinion, 8%


Representative or random suffix? •  Question

–  “The FDA has proposed a policy that would require the use of a distinct non-proprietary scientific name for all products, whether originator or biosimilar. This is intended to aid the process of pharmacovigilance and accurate prescribing and dispensing of medicines. In March of 2015, the FDA approved the first biosimilar product for the U.S. market. The product currently carries the scientific name “filgrastim-sndz.” In the case of filgrastim-sndz, the suffix “sndz” is intended to identify Sandoz as the manufacturer of the product. More recently, the FDA has proposed a further change to the naming of biologic products. In the case of filgrastim-sndz, the name would become “filgrastim-bflm,” where the suffix carries no meaning and is not indicative of the product’s manufacturer. For future product approvals, which of the following would you prefer?” Manufacturer

suffix, 77%

Random suffix, 15%

No opinion, 8%


Why representative / random?

•  See verbatim responses in attached MS Word file.


Suffix content

47%

7%

38%

21%

6%

11%

7%

31%

1%

30%

0% 20% 40% 60% 80% 100%

Representative suffix is preferable

Random suffix is preferable

% of Respondents

Completely agree Somewhat agree No opinion

Somewhat disagree Completely disagree

•  Question –  “For purposes of accurately identifying the medicine, a

representative suffix – for example, one that resembles the manufacturer name – is preferable.”

•  Question

–  “For purposes of accurately identifying the medicine, I prefer a suffix that is a random 4-digit string of characters.”


LABEL CONTENT U.S. pharmacists, biosimilars and

Indicates biosimilar

1%

2%

13%

23%

58%

0% 10% 20% 30% 40% 50% 60% 70%

1 - Not at all important

2

3

4

5 - Very important

% of Respondents

•  Question –  “How important is it that a product label for a biosimilar

clearly indicates that it is a biosimilar?”


Mean = 4.36

Defines biosimilarity

•  Question –  “How important is it that a product label for a biosimilar

defines what biosimilarity means?”

3%

10%

20%

30%

37%

0% 5% 10% 15% 20% 25% 30% 35% 40%


2

3

4

5 - Very important

% of Respondents


Mean = 3.89

Analytical data

•  Question –  “How important is it that the biosimilar label includes

the analytical data developed by the biosimilar sponsor to demonstrate its analytical similarity to the reference product?”

2%

8%

19%

37%

34%

0% 5% 10% 15% 20% 25% 30% 35% 40%


2

3

4

5 - Very important

% of Respondents


Mean = 3.92

Clinical data

•  Question –  “How important is it that the biosimilar label includes

the clinical data, if any, submitted to FDA by the biosimilar sponsor to demonstrate that it is highly similar to the reference product?”

3%

8%

17%

36%

35%

0% 5% 10% 15% 20% 25% 30% 35% 40%


2

3

4

5 - Very important

% of Respondents


Mean = 3.93

Post-marketing data

•  Question –  “How important is it that post-marketing data related to

the biosimilar be added to the biosimilar label?”

2%

8%

24%

32%

33%

0% 5% 10% 15% 20% 25% 30% 35%


2

3

4

5 - Very important

% of Respondents


Mean = 3.84

Reference brand name

•  Question –  “How important is it that the label mentions the

reference product by brand name so as to clarify the precise relationship between the originator product and the biosimilar product?”

•  Segment Difference –  Retail pharmacists have a higher average rating of

importance for this than hospital pharmacists. 4.14 vs. 3.79

4%

5%

19%

35%

36%

0% 5% 10% 15% 20% 25% 30% 35% 40%


2

3

4

5 - Very important

% of Respondents


Mean = 3.93

Approved and non-approved indications

•  Question –  “How important is it that the label explicitly states that

specific indications or conditions of use that are approved for the originator product are NOT approved for the biosimilar product?”

•  Segment Difference –  Retail pharmacists have a higher average rating of

importance for this than hospital pharmacists. 4.32 vs. 3.98

3%

5%

16%

28%

48%

0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% 55%


2

3

4

5 - Very important

% of Respondents


Mean = 4.11

Originator vs. biosimilar data

•  Question –  “How important is it that the label clearly distinguishes

those data generated by the biosimilar sponsor from those generated by the originator sponsor?”

3%

6%

21%

35%

34%

0% 5% 10% 15% 20% 25% 30% 35% 40%


2

3

4

5 - Very important

% of Respondents


Mean = 3.92

Clinical similarity

•  Question –  “How important is it that the label includes all relevant

clinical similarity data, including clinical immunogenicity findings, from the biosimilar product development?”

2%

7%

23%

35%

33%

0% 5% 10% 15% 20% 25% 30% 35% 40%


2

3

4

5 - Very important

% of Respondents


Mean = 3.89

Data source

•  Question –  “How important is it that the label makes clear which

indications were studied by the biosimilar sponsor and which indications were approved based on extrapolation from studies in other indications?”

3%

4%

17%

33%

43%

0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50%


2

3

4

5 - Very important

% of Respondents


Mean = 4.09

Interchangeability / Substitution

•  Question –  “How important is it that a product label clearly

indicates a biosimilar is or is not interchangeable, meaning it may be eligible for automatic substitution by a pharmacist depending on the state in which the prescription is written?”

2%

2%

8%

24%

64%

0% 10% 20% 30% 40% 50% 60% 70%


2

3

4

5 - Very important

% of Respondents


Mean = 4.47

Questionnaire

October 2015 Biosimilar Naming and Labeling 35

Biosimilars Naming and Labeling

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